SUNBURN RELIEF- lidocaine hcl 0.5% gel

Sunburn Relief by

Drug Labeling and Warnings

Sunburn Relief by is a Otc medication manufactured, distributed, or labeled by WALMART INC., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Inactive ingredients

water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5

QUESTIONS

Questions?  1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY Walmart Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by Bayer Healthcare,

LLC, owner of the registered trademark Solarcaine

Cool Aloe Burn Relief Formula.

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

Principal Display Panel

NDC: 79903-037-34

EquateTM

Compare to Solarcaine Cool Aloe Burn Relief Formula active ingredient*

Burn

Relief Gel

WITH LIDOCAINE

Pain Relieving Gel

with Aloe

Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Relief from:

• sunburn
• Cuts & scrapes
• Insect bites

Moisturizer

NET WT 8 OZ (226g)

INGREDIENTS AND APPEARANCE

SUNBURN RELIEF 
lidocaine hcl 0.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-037-34	226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/23/2020

Labeler - WALMART INC. (051957769)

Registrant - Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		088520668	manufacture(79903-037)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(79903-037)